Trends in pregnancy labeling and data quality for US-approved pharmaceuticals

Mazer‐Amirshahi, Maryann; Samiee-Zafarghandy, Samira; Gray, George M.; Anker, Johannes N. van den

doi:10.1016/j.ajog.2014.06.013

Cited by 51 publications

(40 citation statements)

References 9 publications

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“…(14–18) Instead, their safety and toxicity data were obtained from either post-marketing surveillance or late stage retrospective studies. Similarly, their efficacy and dosing data were extrapolated from studies conducted in men or non-pregnant women.…”

Section: The State Of Drug Research In Pregnancymentioning

confidence: 99%

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Epidemiology of medications use in pregnancy

Ayad

Costantine

2015

Seminars in Perinatology

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The use of prescribed and over-the-counter medications in pregnancy is on the rise. Many women become pregnant at an older age and with pre-existing medical conditions that require pharmacotherapy. In addition, pregnancy is associated with profound changes in the physiology of virtually every organ in the body, which affect medications’ pharmacokinetics and pharmacodynamics. Despite all of these, pregnant women are still considered therapeutic orphans as the majority of current therapeutics were never studied in pregnancy. The goals of this review are to synthesize the available information regarding the epidemiology of medications use and the state of drug research in pregnancy, in an effort to highlight the need for pharmacologic research in pregnancy.

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Section: The State Of Drug Research In Pregnancymentioning

confidence: 99%

“…In a review of the labeling data of 213 new pharmaceuticals approved by the FDA between 2003 and 2012, only 5% of them included human data in their pregnancy section, and almost half did not have any breastfeeding data at all. (18)…”

Section: The State Of Drug Research In Pregnancymentioning

confidence: 99%

Epidemiology of medications use in pregnancy

Ayad

Costantine

2015

Seminars in Perinatology

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“…An estimated 90% take at least one medication during each pregnancy (16,17), and more than half take at least one medication or more during the first trimester (16,18). Very few studies have examined drug dosing and consequences as it pertains to the physiologic changes and trans-placental factors during pregnancy (16). …”

Section: Special Populationsmentioning

confidence: 99%

Special population considerations and regulatory affairs for clinical research

Grimsrud¹,

Sherwin²,

Constance³

et al. 2015

Clinical Research and Regulatory Affairs

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Special populations, including women (non-pregnant and pregnant), pediatrics, and the elderly, require additional consideration with regard to clinical research. There are very specific regulatory laws, which protect these special populations, that need to be understood and adhered to in order to perform clinical research. This review provides a broad overview of some of the physiological differences in special populations and discusses how these differences may affect study design and regulatory considerations. These various special populations, with respect to regulatory affairs, are clearly defined within the Code of Federal Regulations. The definition of “special population” exists to provide enhanced awareness of their vulnerabilities, thereby allowing the creation of regulatory guidance aimed to decrease injury or outright harm. Currently, progress is being made to be more inclusive of special populations in clinical trials. This reflects changing attitudes towards drug information, with it being more representative of those patients that will ultimately be prescribed or exposed to the therapy. However, all research undertaken in these populations should be performed in a manner that ensures all protections of each participant are upheld.

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“…The new system is more explicit about the sources of data on the label, and it is likely to further expose how little human data exist for most drugs that are available in the United States (92.9% of pharmaceutical drugs obtain pregnancy data from animal studies; 5.2% have human pregnancy data). 5,6 The detailed information in the new narrative summaries may also make the decision-making process between patients and physicians more complex and time consuming. Previously, physicians used pregnancy categories as simple surrogates for risk stratification, with A being considered the safest and X the most dangerous.…”

mentioning

confidence: 99%